YU LONG SHENG DISPOSABLE THERMOMETER SHEATHS, MODELS YLS-01 AND YLS-02

K102508 · Yu Long Sheng Technology Co., Ltd. · FLL · Jan 10, 2011 · General Hospital

Device Facts

• Record ID: K102508
• Device Name: YU LONG SHENG DISPOSABLE THERMOMETER SHEATHS, MODELS YLS-01 AND YLS-02
• Applicant: Yu Long Sheng Technology Co., Ltd.
• Product Code: FLL · General Hospital
• Decision Date: Jan 10, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2

Intended Use

YLS-01 disposable thermometer sheath is intended for use as a barrier that is used as an accessory to oral or rectal for digital thermometers. This thermometer sheath is non-sterile and is intended for single patient use only.

Device Story

Yu Long Sheng Disposable Thermometer Sheath (model YLS-01) is a plastic barrier accessory for oral or rectal digital thermometers. Device consists of EVA film with upper and lower exterior protection paper. Used in clinical or home settings to prevent cross-contamination between patients during temperature measurement. Healthcare providers or patients slide the digital thermometer into the sheath before use and discard after a single use. Device is non-sterile and latex-free.

Clinical Evidence

No clinical data. Evidence consists of bench testing: material safety, biocompatibility (ISO 10993-5 and ISO 10993-10), and product performance characteristics (ASTM F1104-98(2003)).

Technological Characteristics

Materials: EVA film with upper and lower exterior protection paper. Dimensions: 94 x 26 mm. Non-sterile. Latex-free. Performance testing per ASTM F1104-98(2003). Biocompatibility per ISO 10993-5 and ISO 10993-10.

Indications for Use

Indicated for use as a barrier accessory for oral or rectal digital thermometers in patients requiring temperature measurement. Intended for single patient use; non-sterile.

Regulatory Classification

Identification

A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.

Special Controls

(1) Device is not a clinical thermometer with telethermographic functions; (2) Device is not a clinical thermometer with continuous temperature measurement functions; and (3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.

Predicate Devices

• GOOD MEDY Disposable Thermometer Sheaths (K061007)

Submission Summary (Full Text)

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Yuläng 玉隆塑膠廠

Tel: [phone]

K102508

# " 510(K) SUMMARY "

JAN 1 0 2011

Submitter's Name: YU LONG SHENG TECHNOLOGY CO., LTD. 1.

> No. 76, Mingqiang Road, Pingshan Shabo Community, Pingshan District, Shen Zhen City, Guangdong Province, China.

Contact person: Pearl Chen Contact Information: Fax No: [phone]; E-mail: [e-mail]

- 2. Date summary prepared: November 10, 2010
### 3. Device Name:

- Classification name: Thermometer, Electronic, Clinical .
- Classification number: { FLV, Class II .
- 880.2910 Regulation Name: .
- . Proprietary name: Yu Long Sheng Disposable Thermometer Sheath
- � Common Name: Disposable Thermometer Sheaths
- . Model: YLS-01 for digital thermometer
- Predicate Device: GOOD MEDY Disposable Thermometer Sheaths, K061007 ●

## 4. Indications for Use:

YLS-01 disposable thermometer sheath is intended for use as a barrier that is used as an accessory to oral or rectal for digital thermometers. This thermometer sheath is non-sterile and is intended for single patient use only.

- 5. Description of the device:
The Yu Long Sheng Disposable Thermometer Sheath(model YLS-01) is a plastic covering used for oral/rectal digital thermometer. This device is not made with natural rubber latex

- Summary of the non-clinical testing data included in the submission : 6.
- i. Material safety test conducted by SGS.
- 1SO10993-5 and ISO10993-10 biocompatibility test conducted by SUPERLAB. ii.
- ASTM E1104:03 product characteristics test conducted by Wincent Consultant. iii.

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Yulöng
玉隆玉隆塑料有限公司

Tel: [phone]: Fox: 0755_00 E-mail:[e-mail]

- Legally marketed device for substantial equivalence comparison: 7. GOOD MEDY Disposable Thermometer Sheaths, K061007.
#### 8. Comparison information

As the following comparison table.

| Comparison feature | Model | |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| | Yu Long Sheng YLS-01 | Good Medy (K061007) |
| Device Name | Yu Long Sheng Disposable<br>Thermometer Sheaths | Good Medy Disposable<br>Thermometer Sheaths |
| Indication for use | Use as a barriers that is used<br>as an accessory to oral or<br>rectal for digital thermometer | Use as a barriers that is used<br>as an accessory to oral or<br>rectal for digital thermometer |
| Construction | EVA film with upper and<br>Lower exterior protection<br>paper. | EVA film with upper and<br>Lower exterior protection<br>paper. |
| Use type | For single use | For single use |
| Size of single piece | 94 x 26 mm | 124 x 34 mm |
| Package | 50 pcs in one packaging unit | 1000 pcs in one packaging unit |
| Sterile package | Non-sterile package | Non-sterile package |
| Test Data | 1. Material safety test.<br>2. Biocompatibility test<br>according to ISO10993-5<br>& ISO10993-10.<br>3. Performance test<br>according to ASTM<br>F1104-98(2003) | 1. Material Safety test.<br>2. Biocompatibility test<br>according to ISO 10993-5<br>& ISO10993-10. |

#### 9. Summary for substantial equivalence comparison:

The new devices, Yu Long Sheng Disposable Thermometer Sheath, model YLS-01 for digital thermometer is substantially equivalent to the predicate devices: GOOD MEDY Disposable Thermometer Sheaths, K061007. The intended use of the two devices is the same, and the overall dimensions are similar. The two devices also had passed the biocompatibility test by ISO10993, same non-sterile and not made with natural rubber latex. Thus the new devices are substantially equivalent to the devices.

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Image /page/2/Picture/0 description: The image shows a partial view of a logo or emblem. On the left, a portion of the text "DEPARTMENT OF HEALTH" is visible, arranged vertically along the edge. To the right of the text is a stylized graphic consisting of three curved lines stacked on top of each other, resembling a simplified human figure or abstract design. The overall impression is that of an official seal or emblem, likely associated with a health-related organization or government department.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Yu Long Sheng Technology Company, Limited C/O Mr. Tony C. Chang Wincent Consultant Company, Limited No. 15, Alley 71, Chenping 156 Beitun District Taichung China (Taiwan) 406

JAN 10 2011

Re: K102508

Trade/Device Name: Yu Long Shen Disposable Thermometer Sheath/Model YLS-01 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: December 17, 2010 Received: December 20, 2010

Dear Mr. Chang:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2- Mr. Chang

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,
Jamsd Kusoztus
for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Tel: [phone]

# Indications For Use

JAN 1 0 2011

510(k) Number (if known): K102508

Device Name: Yu Long Sheng Disposable Thermometer Sheath / Model YLS-01

Indications For Use:

YLS-01 is intended for use as a barrier that is used as an accessory to oral or rectal for digital thermometers. This sheath is non-sterile and is intended for single patient use only.

Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use V (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of

ACDNG for
RICHARD CHAPMAN
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: _______________________________________________________________________________________________________________________________________________________________